Test:IHC-PD-L1 (Pembrolizumab)
Other Test Request Name:

PD-L1 Lung (Pembrolizumab)

Test Composition:

Not Applicable

Intended Use:

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:
  • Samples must be LABELED properly and legibly.
  • The label must match the information on the test request form and on the provided histopathology report.
  • Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
  • FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
  • Must prepare all the necessary documents like Histopathology Report and Doctors Request
Collection/Sample Container:
  • Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage
  • FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:
  • Formalin-fixed paraffin-embedded (FFPE) tissue block
  • 1 H&E stained slide representative of the submitted tissue block.
  • Histopathology report for the submitted tissue block
Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not Applicable

•   Freezer Temperature (-20°C):

Not Applicable

Transport Temperature:
  • Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
  • FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
  • Transport specimen at 15°C ~25 °C (room temperature)
Rejection Criteria:
  • Incorrect/Incomplete information in the Request Form.
  • Improper/Incorrect labeling of tissue blocks or slides.
  • Tissue blocks and slides do not correspond to its histopathology report.
  • Inadequate tissue available on the tissue block.
  • Less than 100 viable tumors seen.
  • Cellblocks (body fluids) submitted.

 

Running Day:

Monday to Friday

Cut Off Time:

Monday to Friday, 7:00 AM

TAT/Releasing of Results:

10 days after cut-off (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

None Specified

Frequently Asked Questions (FAQs):

Not Applicable

Related Words/Test:Not Applicable

 

Test:IHC-PLAP
Other Test Request Name:

• Alkaline Phosphatase, Placental

• PLAP

• PLAP-IHC

Test Composition:

Not applicable

Intended Use:

• Tumor marker, especially in seminoma and ovarian cancer.

 

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary.

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Tuesday, Thursday and Saturday

Cut Off Time:

Day before running day

TAT/Releasing of Results:

10 days (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

Tissues with non-standard fixation will yield less optimal results. 

Frequently Asked Questions (FAQs):

Not applicable

Related Words/Test:Not Applicable

 

Test:IHC-S100
Other Test Request Name:

S100

Test Composition:

Not applicable

Intended Use:

- The immunohistochemical evaluation of S-100 (beta) protein expression is important in the diagnosis of undifferentiated malignant tumors of unknown primary origin and should be included in the so-called primary panel.

- A very sensitive marker for malignant melanoma of all types; a negative staining is exceedingly rare. Because of its low specificity, other markers should be included in a panel for malignant melanoma, such as vimentin and Melan-A.

- May be used in the differential diagnosis of sarcomas (e.g., the distinction between liposarcoma and other myxoid tumors) and spindle cell tumors (e.g., the distinction between schwannoma, leiomyoma and gastrointestinal stromal tumor).

- May be used to aid in the identification of cells of normal and abnormal neuronal and neuroendocrine lineage and as aid in the diagnosis of anaplastic tumors.

Methodology:

Immunohistochemistry (IHC)

Laboratory Section:

Histopathology

Special Instructions/Patient Preparations:

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report

Collection/Sample Container:

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability 

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15oC~30oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

Transport specimen at 15oC -30oC

Rejection Criteria:

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Running Day:

Monday to Saturday

Cut Off Time:

12:00 PM

TAT/Releasing of Results:

- With Reading - 3 to 5 days after receipt of specimen/ messengers arrival or 10 working days (if with special test)

- For Processing Only - 1 day after receipt of specimen/ messengers arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

Reference Interval/Result Interpretation:

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

Limitations/Interferences:

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

Frequently Asked Questions (FAQs):

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

Related Words/Test:

- ImmunoHistoChemistry (IHC)

- S100

 

Test:IHC-SAL-4
Other Test Request Name:

Immunohistochem SAL - 4

Test Composition:

Not applicable

Intended Use:

A novel diagnostic marker for testicular germ cell tumors

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary.

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Tuesday, Thursday and Saturday

Cut Off Time:

Day before running day

TAT/Releasing of Results:

10 days (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

None specified.

Frequently Asked Questions (FAQs):

Not applicable

Related Words/Test:

Testicular germ cell tumors (GCTs)

 

Test:IHC-Sarcomeric
Other Test Request Name:

Not applicable

Test Composition:

Not applicable

Intended Use:

Monoclonal anti-alpha sarcomeric actin has been used as a marker for rhabdomyosarcoma. This antibody is specific to alpha skeletal and alpha cardiac muscle actins. It does not react with smooth muscle tissue.

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary.

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Mondays, Wednesdays and Fridays

Cut Off Time:

Day before running day

TAT/Releasing of Results:

10 days (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

None specified.

Frequently Asked Questions (FAQs):

Not applicable

Related Words/Test:

Striated muscle tissue

 

Test:IHC-SMA
Other Test Request Name:

- Anti-Smooth Muscle Actin

- Anti-Actin, Smooth Muscle

- SMA (1A4)

Test Composition:

Not applicable

Intended Use:

- Used as a discriminator of smooth muscle cell differentiation in the classification of spindled and pleomorphic tumours. Together with cytokeratin, SMA can be used for the identification of granulosa-stromal tumours and myoepithelial tumours.

- SMA is detected in virtually all cases of leiomyomatous tumours, e.g., glomus tumour and leiomyosarcoma, in myofibroblastic tumours, e.g., fibromatoses, myofibosarcoma, myoepithelial tumours, some vascular tumours, e.g., angiomyxoma, haemangiosarcoma, and Kaposi sarcoma, in other mesenchymal tumours such as angioleiomyolipoma, synovial sarcoma, and angiomatoid malignant fibrous histiocytoma, and in ovarian granulosa-stromal tumours.

Methodology:

Immunohistochemistry (IHC)

Laboratory Section:

Histopathology

Special Instructions/Patient Preparations:

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report

Collection/Sample Container:

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability 

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15oC~30oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

Transport specimen at 15oC -30oC

Rejection Criteria:

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Running Day:

Monday to Saturday

Cut Off Time:

12:00 PM

TAT/Releasing of Results:

- With Reading - 3 to 5 days after receipt of specimen/ messengers arrival or 10 working days (if with special test)

- For Processing Only - 1 day after receipt of specimen/ messengers arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

Reference Interval/Result Interpretation:

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

Limitations/Interferences:

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

Frequently Asked Questions (FAQs):

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

Related Words/Test:

- ImmunoHistoChemistry (IHC)

- Anti-Smooth Muscle Actin

- Anti-Actin, Smooth Muscle

- SMA (1A4)

 

Test:IHC-TDT
Other Test Request Name:

Terminal deoxynucleotide transferase

Test Composition:

Not Applicable

Intended Use:

The following CD markers are expressed on specific hemotologic cells. Individual and a series of ihc markers can be run on unknown cells and presence or absence of the antigen can help to characterize the cell of interest.

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary 

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

 Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not Applicable

•   Freezer Temperature (-20°C):

Not Applicable

Transport Temperature:

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Tuesday and Thursday 

Cut Off Time:

Monday 7am and Wednesday 7am

TAT/Releasing of Results:

10 working days (excluding saturdays, sundays and holidays) 

Reference Interval/Result Interpretation:

None specified.

Limitations/Interferences:

None specified.

Frequently Asked Questions (FAQs):

None specified.

Related Words/Test:

None specified.

 

Test:IHC-Thyroglobulin
Other Test Request Name:

Not applicable

Test Composition:

Not applicable

Intended Use:

• useful in positive identification of thyroid carcinomas of the papillary and follicular types. Demonstration of thyroglobulin in a metastatic lesion establishes the thyroid origin of the tumor. Adenocarcinomas of non-thyroidal origin are not reactive.

Methodology:

Immuno histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

Not Applicable

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not Applicable

•   Freezer Temperature (-20°C):

Not Applicable

Transport Temperature:

Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Tuesday and Thursday

Cut Off Time:

 A day before running day

TAT/Releasing of Results:

7 working days excluding saturday, sunday and holidays

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

None specifird.

Frequently Asked Questions (FAQs):

Not Applicable

Related Words/Test:Not Applicable

 

Test:IHC-TTF-1
Other Test Request Name:

Thyroid Transcription Factor 1

Test Composition:

Not applicable

Intended Use:

- TTF1 is useful as marker for pulmonary adenocarcinoma and pulmonary neuroendocrine malignancy, including small cell lung carcinoma.

- It can be used to differentiate primary lung adenocarcinoma from metastasis of extrapulmonary origin (the subgroup of TTF1 positive gastrointestinal adenocarcinomas usually also stain for cdx2). Differential diagnosis of mucinous lung carcinoma (usually TTF1 negative) requires other markers.

- The use of TTF1 immunostaining is a valuable adjunct in differential diagnosis of pleural malignancy. Malignant mesothelioma does not express TTF1 as against peripheral pulmonary adenocarcinoma, which is usually positive.

- Neuroendocrine carcinoma in the skin can be identified as Merkel cell carcinoma if cytokeratin 20 positive and TTF1 negative, and metastatic small cell lung carcinoma if TTF1 positive and cytokeratin 20 negative.

Methodology:

Immunohistochemistry (IHC)

Laboratory Section:

Histopathology

Special Instructions/Patient Preparations:

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report.

Collection/Sample Container:

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Alternative Specimen and Volume Requirement:

Not applicable

Specimen Stability 

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15oC~30oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

Transport specimen at 15°C to 30°C

Rejection Criteria:

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Running Day:

Monday to Saturday

Cut Off Time:

12:00 PM

TAT/Releasing of Results:

- With Reading - 3 to 5 days after receipt of specimen/ messengers arrival or 10 working days (if with special test)

- For Processing Only - 1 day after receipt of specimen/ messengers arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

Reference Interval/Result Interpretation:

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

Limitations/Interferences:

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

Frequently Asked Questions (FAQs):

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

Related Words/Test:

- Immunohistochemistry (IHC)

- Thyroid Transcription Factor 1

 

Test:IHC-Vimentin
Other Test Request Name:

Vimentin

Test Composition:

Not applicable

Intended Use:

- Used as an aid in the identification of endothelial cells, fibroblasts, smooth muscle cells and lymphoid cells.

- When used with cytokeratin, aids in the identification of thyroid carcinomas, pleomorphic adenomas of the salivary gland, ovarian carcinomas and some renal carcinomas

Methodology:

Immunohistochemistry (IHC)

Laboratory Section:

Histopathology

Special Instructions/Patient Preparations:

All specimens must be LABELED properly and legibly. The label must match the information on the test request form and on the provided histopathology report.

Collection/Sample Container:

- Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.

- FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

- Formalin-fixed paraffin-embedded (FFPE) tissue block

- H&E stained slide, representative of the submitted tissue block.

- Histopathology report for the submitted tissue block and slide

- Completely filled out HPD Histopathology Request Form (HPD_F_258)

Note:Submit to HPD Main Laboratory all tissue blocks and slides received.

Alternative Specimen and Volume Requirement:

Not applicable

Specimen Stability 

- FFPE tissue blocks and H&E slides are stable indefinitely when stored properly at room temperature (15oC~30oC).

- Hi-Precision Diagnostics will store FFPE tissue blocks and H&E slides for 10 years, after which samples will be disposed properly according to biosafety disposal guidelines.

•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

Transport specimen at 15°C to 30°C

Rejection Criteria:

- Incorrect/Incomplete information in the HPD Histopathology Request Form

- Improper or insufficient labeling of tissue blocks or slides

- Inadequate tissue available on the tissue block

- Tissue blocks and slides do not correspond to its histopathology report

- Specimen stored and transported outside the required temperature

Running Day:

Monday to Saturday

Cut Off Time:

12:00 PM

TAT/Releasing of Results:

- With Reading - 3 to 5 days after receipt of specimen/ messengers arrival or 10 working days (if with special test)

- For Processing Only - 1 day after receipt of specimen/ messengers arrival

Note: Additional 2 days may be necessary if specimen needs further evaluation and confirmation by another Pathologist

Reference Interval/Result Interpretation:

- The clinical interpretation of any staining, or absence of staining, must be complemented by histological studies and evaluation of proper controls.

- Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.

Limitations/Interferences:

- Ventana recommends fixation in 10% NBF for 6-48 hours.

- Fixation for less than 6 hours is not recommended.

Frequently Asked Questions (FAQs):

Q. What is Immunohistochemistry?

A.Immunohistochemistry or IHC refers to the process of detecting antigens (e.g., proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

Q. Why do we need to undergo Immunohistochemistry test?

A. - Confirm a pathologic diagnosis

      - Differentiate between benign or malignant tumor

      - Detect among different types of tumor

      - Monitor prognosis response to treatment

Related Words/Test:

- Immunohistochemistry (IHC)

- Vimentin

 

Test:IHIC - CD5
Other Test Request Name:

Not applicable

Test Composition:

Not applicable

Intended Use:

• CD5 is a T-cell associated marker that is also expressed by two B-cell neoplasms; lymphocytic leukemia and mantle cell lymphoma. CD5 antigen is expressed in 95% of thymocytes and 72% of peripheral blood lymphocytes.

Methodology:

Immuno Histochemistry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary.

Collection/Sample Container:

Slide holders or mailers for microscope slides; FFPE tissue blocks can either be wrapped in paper or placed in a box.

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

• Formalin-fixed paraffin-embedded (FFPE) tissue block
• 1 H&E stained slide representative of the submitted tissue block.
• Histopathology report for the submitted tissue block

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Indefinite

•   Refrigerated Temperature (2-8°C):

Not applicable

•   Freezer Temperature (-20°C):

Not applicable

Transport Temperature:

• Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)

Rejection Criteria:

• Incomplete information in the Request Form
• Improper or insufficient labeling of tissue blocks or slides
• Inadequate tissue available on the tissue block

Running Day:

Mondays and Fridays

Cut Off Time:

Day before running day

TAT/Releasing of Results:

10 days (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

None specified.

Frequently Asked Questions (FAQs):

Not applicable

Related Words/Test:Not Applicable

 

Test:Immuno Fixation
Other Test Request Name:
  • Paraprotein
  • Serum proteins - immunofixation
  • Immunoelectrophoresis
  • IFS
  • Dysgammaglobulinemia
Test Composition:

Not applicable

Intended Use:

Immunofixation electrophoresis involves initially separating serum proteins by electrophoresis followed by an immunoprecipitation step. It is used to establish the nature of the monoclonal component(s), i.e. IgG, IgA or IgM and the class of the light chain. With specific antisera, particular monoclonal proteins can be identified: free monoclonal kappa and lambda light chains, IgD and IgE.It also reveals oligoclonal immunoglobulins or if the number of different species is very limited.This test is qualitative and does not give the absolute levels of the immunoglobulins concerned.

Methodology:

Immunofixation (gel)

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:

No patient preparation necessary.

Collection/Sample Container:

Red or Gold Tube

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

3 mL Serum

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

48 Hours

•   Refrigerated Temperature (2-8°C):

7 Days

•   Freezer Temperature (-20°C):

28 Days

Transport Temperature:

Transport specimen at 2 – 8 °C (with cold packs)

Rejection Criteria:

• Hemolyzed specimen
• Markedly lipemic specimen
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used

Running Day:

Batch Running 

Cut Off Time:

Friday, 4:00 PM

TAT/Releasing of Results:

2 weeks after cut-off (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Available upon request

Limitations/Interferences:

None specified.

Frequently Asked Questions (FAQs):

Not applicable

Related Words/Test:

Monoclonal antibodies or immunoglobulins in serum or urine, Myeloma

 

Test:Immuno Reproductive Panel 1
Other Test Request Name:

Not Applicable

Test Composition:

CBC, Anti-Nuclear Antibody , Anti-Cardiolipin,PTT ,

Primary Immuno Def. panel 1 (CD3,CD4,CD8,NK CELLS, CD19, & CD20)

Intended Use:

Reproductive immunology refers to the phenomenon of immunological arrest that allows a mother to accept a foreign embryo. The treatment of immune problems addresses infertility, recurrent miscarriages, premature deliveries, and dangerous complications of pregnancy, such as pre-eclampsia.

Methodology:

CBC- Fluorescence Cytometry, Hydrodynamic Focusing, Sodium Lauryl Sulfate (SLS) Method

ANA -Immunofluorescent

Anti-Cardiolipin - ELISA

PTT -multi-wavelength transmitted light detection method

Primary Immuno Def. panel 1-Flowcytometry

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:
  • Inform Special Test Section 1 day before the scheduled sample collection.
  • No patient preparation necessary.
  • Specimen should be at Laboratory at exactly 7AM
Collection/Sample Container:

Sodium Heparin

EDTA

Red tube(DO NOT USE GOLD TUBE or any other type of tube with gel separator)

Citrated Blue top (Plastic)

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

4mL Sodium Heparin Wholeblood

4mL EDTA Wholeblood

3mL Serum

4mL Citrated Plasma (Plastic tube only)

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

4 Hours

•   Refrigerated Temperature (2-8°C):

Not Applicable

•   Freezer Temperature (-20°C):

Not Applicable

Transport Temperature:

CBC, Primary Immuno Def. panel 1 (CD3,CD4,CD8,NK CELLS, CD19, & CD20)- 15°C ~25 °C (room temperature)

Anti-Nuclear Antibody , Anti-Cardiolipin,PTT -Transport specimen at 2 – 8 °C (with cold packs)

Rejection Criteria:
  • Exceeded sample stability requirement
  • Quantity not sufficient
  • Improperly labeled specimen
  • Improper collection tube used
  • Clotted Sample
  •  Over-filled or Under-filled tube
  •  Specimen in glass satellite tube
  • Hemolyzed specimens
Running Day:

Monday to Thursday 7am

Cut Off Time:

Monday to Thursday - 7am(exact time)

TAT/Releasing of Results:

5  working days (excluding saturday, sunday and holidays)

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

Not Applicable

Frequently Asked Questions (FAQs):

Not Applicable

Related Words/Test:

Not Applicable

 

Test:Immuno Reproductive Panel 2
Other Test Request Name:

Not Applicable

Test Composition:

ANA Immunofluorescent

Anti-Smith

Anti-dsDNA

Anti-SCL

Anti-Histone

Intended Use:

Reproductive immunology refers to the phenomenon of immunological arrest that allows a mother to accept a foreign embryo. The treatment of immune problems addresses infertility, recurrent miscarriages, premature deliveries, and dangerous complications of pregnancy, such as pre-eclampsia.

Methodology:

Immunofluorescent

Laboratory Section:

Special test

Special Instructions/Patient Preparations:
  • Inform Special Test Section 1 day before the scheduled sample collection.
  • No patient preparation necessary.
  • Specimen should be at Laboratory at exactly 7AM
Collection/Sample Container:

Red tube (DO NOT USE GOLD TUBE or any other type of tube with gel separator)

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

5mL Serum

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

Not Applicable

•   Refrigerated Temperature (2-8°C):

7 days

•   Freezer Temperature (-20°C):

3 months

Transport Temperature:

Transport specimen at 2 – 8 °C (with cold packs)

Rejection Criteria:

• Gold top tube (Collection tube WITH gel separator)
• Markedly lipemic serum
• Improperly labeled specimens
• Hemolyzed specimens
• Quantity not sufficient
• Specimens exceeded sample stability requirement

Running Day:

Tuesday 7am

Cut Off Time:

Monday 7am  (exact time)

TAT/Releasing of Results:

5 working days excluding saturday, sunday and holidays

Reference Interval/Result Interpretation:

Not Applicable

Limitations/Interferences:

Not Applicable

Frequently Asked Questions (FAQs):

Not Applicable

Related Words/Test:Not Applicable

 

Test:Immunofix Electro (Serum)
Other Test Request Name:
  • Immunofixation Electrophoresis
  • IFX
  • Immunoelectrophoresis
  • Protein Electrophoresis and Immunobinding Serum
  • IFS
  • Proteinogram
  • Proteins - electrophoresis
  • Serum proteins - immunofixation
  • Dysgammaglobulinemia
Test Composition:

Not applicable

Intended Use:

The IFX test is often used to diagnose multiple myeloma or Waldenstrom’s macroglobulinemia, when symptoms of the disorders are present. Both conditions produce abnormal Ig.

Methodology:

Electrophoresis and Immunobinding

Laboratory Section:

Special Test

Special Instructions/Patient Preparations:
  • No patient preparation necessary.

 

 

Collection/Sample Container:

Red or Gold Tube

Specimen and Volume Requirement
Note:Follow tube manufacturer recommendation.
:

3 mL Serum

Alternative Specimen and Volume Requirement:

Not Applicable

Specimen Stability  
•   Room Temperature (15-25°C):

24 Hours

•   Refrigerated Temperature (2-8°C):

7 Days

•   Freezer Temperature (-20°C):

28 Days

Transport Temperature:

Transport specimen at 2 – 8 °C (with cold packs)

Rejection Criteria:
  • Hemolyzed specimen
  • Markedly lipemic specimen
  • Exceeded sample stability requirement
  • Quantity not sufficient
  • Improperly labeled specimen
  • Improper collection tube used
Running Day:

Batch Running 

Cut Off Time:

Friday, 4:00 PM

TAT/Releasing of Results:

2 weeks after cut-off (excluding Saturdays, Sundays and Holidays)

Reference Interval/Result Interpretation:

Available upon request

Limitations/Interferences:

None Specified.

Frequently Asked Questions (FAQs):

Not Applicable

Related Words/Test:

Serum Protein Electrophoresis, Protein ELP, SPE, SPEP, Urine Protein Electrophoresis, UPE, UPEP, IFE, CSF Protein Electrophoresis, Protein Electrophoresis, Immunofixation Electrophoresis